Regulatory Oversight and Compliance

The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.

The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.

Value assessment initiatives are expected to have a major impact on drug use and reimbursement.

FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.

he guidance addresses the good manufacturing practice for managing quality in APIs.

Efforts to accelerate drug development will alter fee structure and require ready production sites.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

A number of organizations have analyzed and estimated the size of pharma’s counterfeit and diversion problem.

As criminals duplicate the latest overt security technologies, pharmaceutical manufacturers are evaluating covert and layered approaches to fight counterfeiting, theft, and illegal product diversion.

Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.

FDA and EMA set up new working group on the development of treatments for rare diseases.

Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.

NICE estimates asfotase alfa will cost £367,000 per patient per year.

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.

The agency clarifies how FDA determines when a risk evaluation and mitigation strategy is necessary.

On Sept. 19, 2016, FDA announced that it has granted accelerated approval to Exondys 51 (eteplirsen), an injection for the treatment of Duchenne muscular dystrophy (DMD). The drug is marketed by Sarepta Therapeutics in the United States and is currently the only approved treatment for DMD. In light of the approval, Sarepta shares catapulted 76%, Seeking Alpha reported.

EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.

The agency recommended approval of 11 drugs, including three cancer drugs, in September.

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.

The agency has recommended marketing authorization for Ibrance in the European Union.

In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.

Regulatory agencies meet to discuss approaches to the development of antibacterial agents.

Siegfried Schmitt, principal consultant, PAREXEL International, discusses how to find the root cause of the problem.

Industry experts discuss recent trends in modular manufacturing.

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.